Evidence map›Paper›PMID 36101813›Full record

ArticleInternational journal of clinical practice2022

The Safety and Effectiveness of Infliximab Biosimilar in Managing Rheumatoid Arthritis: A Real-Life Experience from Jordan.

Khaldoon Alawneh, Abdel-Hameed Al-Mistarehi, Ali Qandeel, Ruba Jaber, Safwan Alomari, Khalid A Kheirallah

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in International journal of clinical practice, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 49% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 2 countries.

Khaldoon AlawnehDepartment of Internal Medicine, Faculty of Medicine, Jordan University of Science and Technology, Irbid, Jordan.ORCID https://orcid.org/0000-0001-5505-3183
Abdel-Hameed Al-MistarehiDepartment of Public Health and Family Medicine, Faculty of Medicine, Jordan University of Science and Technology, Irbid, Jordan.ORCID https://orcid.org/0000-0003-4713-8536
Ali QandeelDepartment of Rheumatology, Prince Hamzah Hospital, Amman, Jordan.
Ruba JaberClinical Research and Development Department, Hikma Pharmaceuticals LLC, Amman, Jordan.ORCID https://orcid.org/0000-0001-9084-1580
Safwan AlomariJohns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID https://orcid.org/0000-0001-7368-0404
Khalid A KheirallahDepartment of Public Health and Family Medicine, Faculty of Medicine, Jordan University of Science and Technology, Irbid, Jordan.ORCID https://orcid.org/0000-0003-4504-4472
Jordan University of Science and Technology · JOJohns Hopkins University · USThe Farah Hospital · JO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Infliximab (IFX) biosimilar was the first biosimilar approved in Jordan in 2014, with limited evidence of its safety and effectiveness from the Middle East and North Africa (MENA) region. Thus, this study aimed to evaluate the safety and effectiveness of IFX biosimilar in active rheumatoid arthritis (RA) patients over 34 weeks by investigating (1) the adverse events (AEs), serious adverse events (SAEs), and therapy discontinuation and (2) the score changes of the 28-Joint Disease Activity Score (DAS28) and the Health Assessment Questionnaire Disability Index (HAQ-DI). Methods: This multicenter prospective cohort study collected clinical parameters within hospital settings every four weeks. The numbers and percentages of observed AEs and SAEs were informed. The DAS28 utilizing Erythrocyte Sedimentation Rate (ESR), HAQ-DI, and ESR were reported at baseline and 14th and 30th weeks; thus, they were reported as means (SD). Results: A total of 22 RA patients were enrolled and initiated IFX biosimilar, of which nine (41.0%) discontinued the study, but their data were analyzed up to the point of withdrawal. A total of 35 AEs were reported in 14 patients, including two (5.7%) SAEs. None of the participants discontinued treatment due to AEs. The mean (SD) score of DAS28-ESR significantly decreased from 6.55 (1.16) at baseline to 4.59 (1.45) at week 14 ( Conclusion: IFX biosimilar demonstrated safety and effectiveness in managing RA patients bringing real-world clinical support for biosimilars' role in rheumatology.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidBiosimilar PharmaceuticalsHumansInfliximabJordanProspective StudiesAntirheumatic AgentsBiosimilar PharmaceuticalsInfliximab

Identifiers

PMID36101813
PMCPMC9439897
OpenAlexW4293162410

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.